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Urine biomarkers for necrotizing enterocolitis and sepsis

a technology of enterocolitis and sepsis, which is applied in the field of urine biomarkers for necrotizing enterocolitis and sepsis, can solve the problems that laboratory tests and diagnostic imaging fail to capture the nuanced differences between these entities during their onset and progression, and achieve the effect of predicting the responsiveness of a patien

Inactive Publication Date: 2014-06-12
RES INST AT NATIONWIDE CHILDRENS HOSPITAL +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes methods for diagnosing and predicting outcomes for NEC (necrotizing enterocolitis) and sepsis, which are medical conditions that affect infants and young children. These methods involve analyzing the expression levels of certain genes in a patient's body fluid, such as urine, and comparing them to a reference to make a diagnosis or predict the patient's response to treatment. The invention provides tools for early diagnosis and treatment of these conditions, which can improve outcomes for affected patients.

Problems solved by technology

However, there is considerable overlap in the early clinical presentation of NEC, IP and sepsis in newborns.
Currently utilized clinical parameters including laboratory tests and diagnostic imaging fail to capture the nuanced differences between these entities during their onset and progression.

Method used

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  • Urine biomarkers for necrotizing enterocolitis and sepsis
  • Urine biomarkers for necrotizing enterocolitis and sepsis
  • Urine biomarkers for necrotizing enterocolitis and sepsis

Examples

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example 1

[0138]Necrotizing enterocolitis (NEC) is a major cause of overall neonatal morbidity and mortality. Disease outcome for infants with NEC is largely determined by the degree of clinical progression. Generally, half of affected infants recover with medical therapy alone (NEC M=medical class) and 30-50% develop progressive disease requiring surgery or resulting in death (NEC S=surgical class). Most of the disease associated morbidity, and nearly all of the mortality, occurs in the cohort with progressive disease requiring surgery. Previous attempts to identify clinical parameters that could reliably identify infants with NEC most likely to progress to severe disease have been unsuccessful. We hypothesized that an integrative analysis of clinical parameters along with protein biomarkers would result in a predictive algorithm of NEC progression. A multivariate analysis of patients (NEC 43 M and 26 S) using the standard NEC classification scheme of Bell failed to differentiate NEC outcome...

example 2

Methods

[0187]Patient Population.

[0188]This study was approved by the human subjects' protection programme at each participating institution (Stanford protocol ID 23091). Informed consent was obtained from the parents of all enrolled subjects. Patient contributions by institution included: Baylor / Texas Children's Hospital (n=184), Yale-New Haven Children's Hospital (n=158), UCSF / Benioff Children's Hospital (n=79), Boston Children's Hospital (n=75), UCLA / Mattel Children's Hospital (n=42), Johns Hopkins Children's Center (n=22), Stanford / Lucile Packard Children's Hospital (n=16) and Children's Hospital of Philadelphia (n=11). Complete data collection including patient-specific demographic, clinical and laboratory data were prospectively collected from a total of 550 infants. Those with incomplete data collection were excluded from the study.

[0189]Urine samples were collected from a subset of 65 infants with suspected NEC. Patient contributions by institution included: Baylor / Texas Chil...

example 3

[0218]Necrotizing enterocolitis (NEC) is an inflammatory condition of the neonatal gastrointestinal (GI) tract most strongly associated with prematurity and the initiation of enteral feeding. The underlying etiology remains poorly understood, but is thought to be multifactorial, involving factors inherent to the premature neonate and its environment. Specific features believed to be involved in the development of NEC include an underdeveloped GI mucosal barrier, immature innate and humoral immunity, uncoordinated intestinal peristalsis, and pathogenic bacterial overgrowth (Lin et al., Necrotizing enterocolitis: recent scientific advances in pathophysiology and prevention. Seminars in perinatology. 2008; 32:70-82). Despite many advances in neonatal intensive care, NEC continues to be a major source of morbidity and mortality in preterm infants. It is diagnosed in 1% to 5% of all neonatal intensive care unit (NICU) patients with an incidence of up to 15% in infants weighing less than ...

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Abstract

Aspects of the invention include methods, compositions, and kits for diagnosing Necrotizing Enterocolitis (NEC), for diagnosing sepsis, for providing a prognosis for a patient with NEC, and for predicting responsiveness of a patient with NEC to medical intervention. These methods find use in a number of applications, such as diagnosing and treating infants who are suspected of having NEC, intestinal perforation (IP), or sepsis.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]Pursuant to 35 U.S.C. §119 (e), this application claims priority to the filing date of U.S. Provisional Patent Application Ser. No. 61 / 732,098, filed Nov. 30, 2012 and PCT Application No. PCT / US2012 / 042275, filed Jun. 13, 2012, which claims priority to U.S. Provisional Patent Application Ser. No. 61 / 496,684, filed Jun. 14, 2011; the full disclosures of which are herein incorporated by reference.GOVERNMENT RIGHTS[0002]This invention was made with Government support under contract RR025742 awarded by the National Institutes of Health. The Government has certain rights in this invention.FIELD OF THE INVENTION[0003]This invention pertains to the fields of necrotizing enterocolitis and sepsis.BACKGROUND OF THE INVENTION[0004]Necrotizing enterocolitis (NEC), intestinal perforation (IP) and sepsis are three life-threatening gastrointestinal diseases among neonates and together constitute a leading cause of overall morbidity and mortality in prem...

Claims

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Application Information

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IPC IPC(8): G01N33/68
CPCG01N33/6893G01N2800/067G01N2800/26
Inventor LING, BRUCE XUEFENGSYLVESTER, KARL G.MOSS, R. LAWRENCE
Owner RES INST AT NATIONWIDE CHILDRENS HOSPITAL
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